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lancet-study-design

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Use to lock study design and mandatory prospective registration for a Lancet clinical manuscript — trial registration before enrollment, protocol + statistical analysis plan, and design rigor (randomization, allocation concealment, blinding, pre-specified endpoints, power, ITT). Covers observational design choices too.

When to use

• Planning or writing up a clinical trial
• Planning or writing up a major observational study
• Verifying trial registration timing
• Checking for protocol and pre-specified statistical analysis plan
• Assessing RCT design rigor
• Evaluating observational design choices

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